WASHINGTON, D.C. - Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement after introduction of legislation (HR 5009) in the U.S. House of Representatives to streamline CMS's coverage and reimbursement process for innovative medical technologies:

"FDA has an established process to identify new breakthrough technologies for serious illnesses and to give them priority review. We support reforms to that process in other pending legislation. The legislation introduced today addresses the fact that there is no similar process at CMS to ensure patients have access to these devices and diagnostics in a timely manner.

"As a result, once FDA determines a breakthrough technology is safe and effective, coverage and reimbursement delays at CMS frequently deny Medicare patients the opportunity to receive them - often for years after FDA approval. Patients deserve access to these life-changing technologies in a more timely fashion.

"Under the legislation, for any new device or diagnostic designated as a breakthrough technology and deemed safe and effective by FDA, CMS would provide immediate transitional coverage for three years. During the three-year period, the therapy would receive a predictable reimbursement, and CMS could specify what additional data, if any, would be needed to continue coverage after the three-year period.

"In addition, the legislation would make improvements to CMS's existing New Technology Add-on Payment (NTAP) program to reduce coverage and payment disincentives that limit prompt patient access to innovative technologies.

"Taken together, the breakthrough policy proposal and NTAP reforms would both stimulate development of important new devices and diagnostics and assure more rapid availability of those treatment options to patients. We look forward to working with members of Congress, CMS and other key stakeholders to move this legislation forward."